The aim of the TRANSITION study was to evaluate tolerability and assess the ideal time for initiating treatment with Entresto (sacubitril/valsartan) in patients stabilised after acute decompensated heart failure (ADHF). The results support that initiation of Entresto is equally tolerable in these patients, if initiated either in hospital or shortly after discharge. 


Methods

TRANSITION was a randomised, multicentre, open-label study that compared the initiation of Entresto in hospitalised HFrEF patients stabilised after an episode of acute decompensated heart failure before vs. after discharge. 

  • The primary endpoint was the proportion of patients achieving the target dose (97 mg/103 mg bid) at the end of week 10 after randomization.
  • Secondary endpoints were 1) the proportion of patients who achieved and maintained a dose of 49/51 or 97/103 mg bid for ≥ 2 weeks leading to week 10 after randomization, 2) the proportion of patients who maintained any dose of sacubitril/valsartan for ≥ 2 weeks leading to week 10, and 3) rates of permanent study drug discontinuations due to adverse events (AEs) during the 10‐week period.

 

The study included patients aged ≥ 18 years, hospitalized for acute decompensated heart failure with (NYHA) class II–IV, blood pressure ≥ 100 mm Hg, and left‐ventricular ejection fraction (LVEF) ≤ 40%. Before initiation of treatment, patients had to be hemodynamically stabile.

Patients were randomized 1:1 to pre-discharge initiation or post-discharge initiation of Entresto. 493 (99%) patients in the pre-discharge group and 489 (97%) patients in the post-discharge group received Entresto either before or after discharge from hospital. Patients were stratified based on any prior use of RAS inhibitors. 


Results

The majority of the patients (88.4% of patients in the pre‐discharge and 84.5% of patients in the post‐discharge group) started with the lowest dose of 24 /26 mg. 

Primary endpoint results: Comparable proportions of patients in the pre‐ and post‐discharge initiation groups achieved the target dose of 97/103 mg bid sacubitril/valsartan at week 10 after randomization [45.4% vs. 50.7%; risk ratio (RR) 0.90; 95% CI, 0.79-1.02, p=0.099].

Secondary endpoint results: 62.1% in the pre-discharge vs. 68.5% in the post-discharge group achieved and maintained a dose of 49/51 or 97/103 mg bid for ≥ 2 weeks leading to week 10 (RR 0.91; 95% CI 0.83–0.99 p=0.034). 86.0% in the pre-discharge vs. 89.6% in the post-discharge group maintained any dose of sacubitril/valsartan for ≥ 2 weeks leading to week 10 (RR 0.96; 95% CI 0.92–1.01, p=0.089). Discontinuation due to adverse events occurred in 7.3% of patients in the pre‐discharge group and 4.9% of patients in the post‐discharge (RR 1.49; 95% CI 0.90–2.46, p=0.117).


Conclusion

Initiation of sacubitril/valsartan in a wide range of HFrEF patients stabilized after an ADHF event, either in hospital or shortly after discharge, is feasible with about half of the patients achieving target dose within 10 weeks.


Reference
  1. Wachter R, Senni M, Belolavek J et al. Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study. Eur J of Heart Fail 2019;21:998-1007.
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SE2204291102 (29 april 2022)
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